跳至主要内容
临床试验/NCT01117701
NCT01117701已完成不适用

Does a Safety Guidewire Adjacent to the Ureteroscope Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Helse-Bergen HF2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
The force needed to passage the ureteroscope up and down in the ureter with and without SGW.

研究概览

简要总结

The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

详细描述

Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.

Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.

The forces needed to move the ureteroscope in the ureter have not been investigated properly.

The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients planned for endoscopic kidney stone treatment

排除标准

  • Known pathology in the ureter

结局指标

主要结局

The force needed to passage the ureteroscope up and down in the ureter with and without SGW.

时间窗: 1 day

The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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